High-intensity Focused Ultrasound in Treatment of Uterine Fibroid

Queen Mary Hospital

Status

Completed

Conditions

Fibroids

Treatments

Procedure: HIFU treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02954744

UW11-204

Details and patient eligibility

About

Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine fibroids.

In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the fibroid. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect of the fibroid on the quality of life of women.

Enrollment

20 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >40 years old, with no future childbearing plans
Age >30 years old, who has tubal sterilization
Significant fibroids symptoms
Clinical uterine size less than 20 weeks gestation
Dominant fibroid less than 10 cm in diameter without areas of necrosis as judged by contrast MRI
No laparotomy scars
Women should be able to give consent

Exclusion criteria

Other pelvic or uncontrolled systemic diseases
Confirmed or suspected pregnancy
Patients who are contraindicated for MRI examination
Patients with thick abdominal wall (>5 cm, as measured by MRI)
Presence or history of acute pelvic inflammatory disease
History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
Cervical fibroids, subserous or submucous fibroids with pedicle, <3.5 cm posterior wall fibroid, fibroids suspicious of malignancy (rapidly growing)